BEUDAMED
    FDA Adverse Event Summary report: N

    STAAR

    MDR report key: 3851386 · Received May 30, 2014

    Report

    Report Number
    MW5036453
    Date Received
    May 30, 2014
    Date of Event
    March 10, 2014
    Report Date
    May 15, 2014
    Manufacturer
    STAAR SURGICAL
    Product Code
    MTA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    STAAR ICL IMPLANTED OU BY ANOTHER SURGEON IN 2007, LASIK ENHANCEMENT 2007, (B)(6) 2014 - VCC 20/25+1 25 CLEAR K WITH LASER FLAP OU REDUCED AT SITE. OD - NO IMAGE ON SPEC. ENDOTHELIAL CELL CT - OS - 2398. SLIT - CATHETER OU. ICL TOUCH TO LENS AND POSTERIOR IRIS. FUNDUS - NL. TOPOGRAPHY SHOWED POOR LASIK ECTASIA OS - OD NL POST LASIK. ICL REMOVED IN COMBINATION WITH PHACO IOL (B)(6) 2014. DIAGNOSIS OR REASON FOR USE: HIGH MYOPIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319725 STAAR ICL MTA STAAR SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention